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The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use with the beam-shrinking handpiece for the removal or significant reduction in intensity of black and/or blue-black tattoos. The laser, without the beam-shrinking handpiece is also indicated for use in combination with the ThermoLase supplied topical lotion in removing or lightening unwanted facial or body hair and for laser skin resurfacing.

The SoftLight Q-Switched Nd:YAG Laser Tattoo Removal System consists of the laser device and a beam-shrinking handpiece which is attached to the aperture of the laser. The handpiece focuses the beam from the laser. The absorption of energy from the beam by the dyes in the tattoo results in the formation and liberation of mechanical and heat energy sufficient to lighten the pigment of the tattoo.

The provided text describes the 510(k) premarket notification for the ThermoLase SoftLight™ Laser Tattoo Removal system, which received clearance in 1999. The information primarily focuses on the device's technical specifications and intended use, with limited details on the study design for its performance data beyond a brief mention of "clinical trials." The acceptance criteria are not explicitly stated as quantitative metrics.

Here's an attempt to extract and organize the requested information based on the provided text:

Acceptance Criteria and Device Performance for Laser Tattoo Removal

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are inferred from the safety and efficacy statements in the "Performance data" section. Specific quantitative thresholds (e.g., a percentage reduction in tattoo intensity) are not provided in the document.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document only mentions "Clinical trials involving human subjects."
• Data Provenance: The trials involved "human subjects" but the country of origin is not specified. The text doesn't indicate if the study was retrospective or prospective, but clinical trials involving treatments and follow-up are typically prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, an MRMC study was not described. The document focuses on the device's direct effect on tattoos, not on comparing human readers' performance with and without AI assistance (as AI assistance is not part of this device).
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable as this is not an AI-assisted device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in the sense that the device's performance was evaluated for its direct effect on tattoos. The "Performance data" section describes the device's standalone action of reducing tattoo intensity on human subjects, without mention of a human-in-the-loop component for this specific indication.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for effectiveness appears to be a subjective assessment of "reduction in intensity" of tattoos. It's likely based on visual assessment by clinicians or potentially patient-reported outcomes, but the specific method (e.g., standardized photography, scoring scales) is not detailed. It is mentioned that "no safety issues" were observed, implying clinical observation as the ground truth for safety.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not provided. This device is a laser system, not an AI model requiring a training set in the conventional sense. The "training" would refer to engineering and design iterations rather than data training.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. This question is relevant for AI/machine learning models, not for a laser device. The "ground truth" during device development would be related to engineering specifications and preclinical testing, which are not outlined here.

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The SoftLight Q-switched Nd: YAG laser is indicated for use in combination with the supplied lotion for skin resurfacing. It is also indicated for the removal or lightening of unwanted facial or body hair.

The ThermoLase SoftLight Q-Switched Nd: YAG Laser is designed to deliver a nominal output of 1.0 Joule per pulse at a fixed operating wavelength of 1064 nm in a collimated beam. The pulse repetition rate is 1, 2, 5 or 10 pulses per second (Hz) and single shot. The Q-Switched output pulses are nominally 6-20 nsec in duration. The output beam is delivered through a 7 mirror articulated arm and beam delivery handpiece which allows an easy access to the treatment site. The collimated laser beam gives a fixed spot size of between 6 and 7 mm at the treatment site. This laser can be set to deliver fluences of between approximately 1 to 3.5 J/cm2. The laser energy and repetition rate settings are adjusted and monitored through a microprocessor-controlled key pad on the control panel of the laser. The accessory topical lotion is a suspension of carbon powder, in a base of Light Mineral Oil, NF.

The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use in combination with a ThermoLase-supplied topical lotion for laser skin resurfacing and for removing or lightening unwanted facial or body hair. The provided document focuses mainly on the device description and regulatory approval process, with limited details on specific acceptance criteria and a detailed study report. Based on the available information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Clinical trials involving human subjects" but does not specify the exact sample size used for these trials.

The data provenance is clinical trials involving human subjects, implying prospective data collection. The country of origin is not explicitly stated, but the company (ThermoLase Corporation) is located in San Diego, California, suggesting the studies likely occurred in the USA or under US regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. Details regarding ground truth establishment, including the number and qualifications of experts (e.g., dermatologists, plastic surgeons), are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in the document. The device is a laser system, not an AI diagnostic tool, so such a study would not be applicable in this context.

6. Standalone (Algorithm Only) Performance Study

This concept is not applicable as the device is a laser system, not a standalone algorithm. Its performance is intrinsically linked to the physical intervention of the laser and the topical lotion with human application.

7. The Type of Ground Truth Used

Based on the performance statements, the ground truth appears to be based on direct observation of clinical outcomes. For skin resurfacing, it's "removal or ablation of skin epidermis," which would likely be assessed visually or histologically by medical professionals. For safety, it's the absence of "safety issues."

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of laser device development, as it's not an AI/machine learning model in the modern sense. The "clinical trials involving human subjects" would serve as the primary data for demonstrating safety and efficacy, analogous to a validation set. The specific sample size for these trials is not provided.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" is not directly applicable. However, the ground truth for the clinical trials (the evidence demonstrating safety and efficacy) was established through clinical observation and assessment by medical professionals over an 8-month follow-up period. This would involve evaluations of skin changes (ablation/removal of epidermis) and the reporting/monitoring of adverse events.

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